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FDA EXPEDITED APPROVAL PLAN: PUBLIC AND CONGRESS

Executive Summary

FDA EXPEDITED APPROVAL PLAN: PUBLIC AND CONGRESS must be aware of risks associated with abbreviated clinical studies, Gilbert McMahon, MD, director of the Clinical Research Center in New Orleans, cautioned in Oct. 21 comments to FDA. "Whenever drugs are permitted on the market with perhaps only 200-500 patients' prior exposure," McMahon noted, "there will be a risk that such drugs will subsequently be shown to produce serious toxicity and indeed occasionally have to be withdrawn from the market. This risk must be clearly understood by the lay public and the Congress." While expressing support for the early release of drugs for life-threatening diseases, McMahon warned, "post-marketing surveillance methodology is not nearly as reliable as pre-marketing requirements under an IND. It simply is a fact that serious side effects of a drug when rare, cannot be ascertained with a few hundred patient exposures." McMahon served as chairman of the Gore/Scheuer Commission in 1983, established to minimize FDA regulations while continuing to protect the public. He also headed the Government Affairs Committee of the American Society for Clinical Pharmacology and Therapeutics for 18 years. McMahon, who has worked primarily in the area of hypertension and cardiovascular diseases, also expressed concern over how FDA will define "life-threatening" diseases. The argument could be made, he said, that because cardiovascular disease is the number one cause of death in the U.S., "antihypertensive drugs or antiarrhythmic agents ought to receive `early release.' The definition of what constitutes a life-threatening disease needs to be clarified."
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